MedDRA
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A subscription-based product of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), MedDRA or Medical Dictionary for Regulatory Activities is a clinically validated international medical terminology dictionary-thesaurus used by regulatory authorities and the biopharmaceutical industry during the regulatory process, from pre-marketing (clinical research phase 0 to phase 3) to post-marketing activities (pharmacovigilance or clinical research phase 4), and for safety information data entry, retrieval, evaluation, and presentation. Also, i
In the Vinony graph
Within Vinony's link graph, MedDRA is referenced by 27 other articles, and connects out to pharmacovigilance, tobacco and cosmetics.
Vinony files it under Pharmacological classification systems and Pharmacology literature.
Its subject is documented across 5 Wikipedia language editions.
Wikidata facts
- Instance of
- glossary
- Subclass of
- medical terminology
- Official website
- www.meddra.org
via Wikidata · CC0
~10 min read
Encyclopedic overview
7 sectionsContents
- MedDRA Vision
- Organization of the dictionary
- MedDRA hierarchy
- Maintenance of MedDRA
- See also
- References
- External links
A subscription-based product of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), MedDRA or Medical Dictionary for Regulatory Activities is a clinically validated international medical terminology dictionary-thesaurus used by regulatory authorities and the biopharmaceutical industry during the regulatory process, from pre-marketing (clinical research phase 0 to phase 3) to post-marketing activities (pharmacovigilance or clinical research phase 4), and for safety information data entry, retrieval, evaluation, and presentation. Also, it is the adverse event classification dictionary.
The first version of MedDRA was released in 1999 in English and Japanese.
Excerpted from Wikipedia’s “MedDRA” article, available under the CC BY-SA 4.0 licence.